(101 days)
No
The summary describes a standard portable X-ray unit with basic control software and image processing capabilities, but there is no mention of AI or ML.
No
The device is described as an X-ray unit intended for acquiring X-ray images for diagnostic purposes, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device may be used for handheld diagnostic imaging of body extremities" and "The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities." The "Device Description" also mentions, "The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites." These statements confirm its intended use for diagnostic purposes.
No
The device description explicitly lists multiple hardware components including an LED display, X-ray generator, X-ray tube assembly, and collimator. While it mentions system control software, this software is integral to the operation of the hardware and the device is not solely software.
Based on the provided information, the NFLK-2501 Portable X-ray Unit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the living body (in vitro).
- NFLK-2501 Function: The NFLK-2501 is an X-ray device. It generates X-rays that pass through the patient's body to create images of internal structures. This is a form of in vivo (within the living body) diagnostic imaging.
- Intended Use: The intended use clearly states the purpose is "acquiring X-ray images of the desired parts of patient's anatomy." This involves imaging the patient directly, not testing specimens from the patient.
Therefore, the NFLK-2501 falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The NFLK-2501 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted:
- The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
- The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
Product codes
IZL
Device Description
The NFLK-2501 consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, a collimator. A cart or a stand can be used with the NFLK-2501. In addition, this unit has preset memory keys to store and select kV. The NFLK-2501 is used with a flat-panel detector.
This device is a mains-powered Mobile X-ray System, designed and manufactured by NEUF.
Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation.
The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), and system control software running on the SYS board. The system control software is for realtime interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, and control the display of the status indicators.
The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites.
This device is not intended for mammography.
The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. The NFLK-2501 is designed for handheld or stand-mounted imaging. The NFLK-2501 can be configured to an optional portable stand/rack (see optional stands in 4.2) or use a stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 30kgs to ensure the mechanical stability and effectiveness of the device.
The cybersecurity risks of the NFLK-2501 have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).
Mentions image processing
The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained physician or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed according to the following standards:
- IEC 60601-1:2005/AMD1:2012 / EN 60601-1:2006/A1:2013 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 / EN60601-1-2:2015 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
- EN 60601-1-3:2008/A11:2016 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008)
- IEC 60601-2-54:2015/EN 60601-2-54:2015 Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X ray equipment for radiography and radioscopy
Guidance Documents utilized:
- "The Content of Premarket Submissions for Software Contained in Medical Devices"
- "Guidance for the Submission of 510(k) for Solid State X-ray Imaging devices"
- Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017.
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 2005
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices issued on October 2018
The device also conforms to:
- 21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products
- 21 CFR 1020.30: Diagnostic x-ray system and their major components
Key results: After analyzing bench tests, it is the conclusion of NEUF Inc. that the NFLK-2501 Portable X-ray Unit is as safe and effective as the predicate device, has the same indications for use, has few technological differences, which are addressed through performance testing and compliance with the standards listed above, thus rendering it substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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August 13, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
NEUF Inc. % Woo Sung Park Consultant MEDMONTS Co., Ltd. Life-officetel 320, 40, 63-ro, Youngdeungpo-gu Seoul, 07345 REPUBLIC OF KOREA
Re: K211383
Trade/Device Name: NFLK-2501 Portable X-ray Unit Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: April 26, 2021 Received: May 17, 2021
Dear Woo Sung Park:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Laurel M. Burk -S. The date of the signature is 2021.08.13, and the time is 10:00:20 -04'00'.
. for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211383
Device Name NFLK-2501 Portable X-ray Unit
Indications for Use (Describe)
The NFLK-2501 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted:
- The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
- The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
| Image: NEUF logo | 005_510(k) Summary | Page: | 005-1 |
|---|---|---|---|
| ------------------ | -------------------- | ------- | ------- |
005_510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K211383
I. SUBMITTER
NEUF Inc.
Address: #103 Production Bldg. 13, Yulchonsandan 4-ro, Haeryong-myeon, Suncheon-si, Jeollanam-do, Republic of Korea (zip : 58034)
Tel : +82-61-740-2830, Fax : +82-31-755-1915 E-mail: ehjung@neufgen.com
Person: Eun Ho Jung
Position: RA/QA
Date Prepared: Apr.24, 2021
II. DEVICE
Name of Device: NFLK-2501 Portable X-ray Unit Regulation Name: Mobile X-ray System Regulation Number: 21 CFR 892.1720 Regulatory Class: Class II Product Code: IZL
III. PREDICATE DEVICE
Manufacturer: MinXray, Inc. Name of Device: MinXray, Model HF120/60H PowerPlus 510(k) number: K040046 Regulation Name: Mobile X-ray System Regulation Number: 21 CFR 892.1720
4
Image /page/4/Picture/0 description: This image contains a logo on the left, the text "005 510(k) Summary" in the center, and the text "Page: 005-2" on the right. The logo appears to be a stylized graphic. The text is arranged horizontally across the image.
Regulatory Class: Class II Product Code: IZL
IV. DEVICE DESCRIPTION
The NFLK-2501 consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, a collimator. A cart or a stand can be used with the NFLK-2501. In addition, this unit has preset memory keys to store and select kV. The NFLK-2501 is used with a flat-panel detector.
This device is a mains-powered Mobile X-ray System, designed and manufactured by NEUF.
Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation.
The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), and system control software running on the SYS board. The system control software is for realtime interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, and control the display of the status indicators.
The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites.
This device is not intended for mammography.
The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. The NFLK-2501 is designed for handheld or stand-mounted imaging. The NFLK-2501 can be configured to an optional portable stand/rack (see optional stands in 4.2) or use a stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand
5
Image /page/5/Picture/0 description: The image contains the word "NEUF" in bold, sans-serif font. To the left of the word is a stylized logo. The logo is a geometric shape with four triangular sections, colored gray, pink, and blue.
can safely carry is 30kgs to ensure the mechanical stability and effectiveness of the device.
The cybersecurity risks of the NFLK-2501 have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).
V. INDICATIONS FOR USE
The NFLK-2501 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted:
-
The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
-
The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The comparison between the overall specifications of predicate device (MinXray HF120/60HPowerPlus™) and the subject device (NFLK-2501 mobile X-ray system) is shown in Table 1.
6
| NEUF | 005_510(k) Summary | Page: | 005-4 | |
|---|---|---|---|---|
| Table 1 Comparison of Technology Characteristics | ||||
| Item | Predicate Device | Subject Device | ||
| MinXray HF120/60HPowerPlus™ (K040046) | NFLK-2501 (without digital imaging) | |||
| Indications for use | This radiographic system is intended for use by a qualified/trained | |||
| physician or technician on both adult and pediatric subjects for | ||||
| taking diagnostic x-rays. Not for mammographic use. | The NFLK-2501 Mobile X-ray System is intended for use by a | |||
| qualified/trained physician or technician for the purpose of acquiring | ||||
| X-ray images of the desired parts of patient's anatomy (including head, | ||||
| cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). | ||||
| The system may be used for handheld diagnostic imaging of body | ||||
| extremities. | ||||
| The system is subject to the following limitations of use when stand | ||||
| mounted: |
- The device may be used for diagnostic imaging of head, cervical
spine, abdomen, lumbar spine, pelvis or extremities. - The device may be used for imaging of the chest when used
without a grid.
This system is not intended for mammography. | | |
| Weight | 17.94 kg | 11.5 kg | | |
| Size | 453292224 mm | 365 * 190 * 185 mm | | |
| Output | 60 mA(0.01-0.1sec), 42 mA (0.11 – 5.0sec) @ 40 - 50 kVDC | 4050kV/5160kV/6170kV/7180kV: 30mA | | |
| | 50 mA(0.01-0.1sec), 35 mA (0.11 – 5.0sec) @ 52 - 60 kVDC | 6170kV: 35mA | | |80kV/81
| | 45 mA(0.01-0.1sec), 31.5 mA (0.11 – 5.0sec) @ 62 - 70 kVDC | 7190kV/91100kV: 25mA | | |
| | 38 mA(0.01-0.1sec), 26.6 mA (0.11 - 5.0sec) @ 72 - 80 kVDC | 8190KV/91100kV: 20mA | | |
| | 33 mA(0.01-0.1sec), 23.1 mA (0.11 – 5.0sec) @ 82 - 90 kVDC | | | |
| | 30 mA(0.01-0.1sec), 21 mA (0.11 – 5.0sec) @ 92 - 100 kVDC | | | |
| | 20 mA(0.01-0.1sec), 14 mA (0.11 – 5.0sec) @ 102 - 120 kVDC | | | |
| NEUF | 005_510(k) Summary | | Page: | 005-5 |
| Use Interface | Up-Down pushbuttons for kVp selections and exposure time
selections with LED indicators mAs indicator | Pushbuttons with LED indicators | | |
| Exposure time | (0.01-0.2sec) in 0.01sec. Step
(0.2-0.4sec) in 0.02sec. Step
(0.4-1.0sec) in 0.05sec Step
(1.0-5.0sec) in 0.1sec Step | (0.014.0, 0.011.8, 2.73.3, 0.011.7, 2.53.2, 0.011.6, 2.54.0,1.3, 2.0~4.0) sec | | |
0.01
| Memory Settings
(technique) | 5 memories | 8 memories | | |
| HF Generator | 85 kHz | 50 kHz | | |
| kW | 2.4 kW peak | 2.5 kW | | |
| kVp | 40-120 kVp | 40-100 kVp | | |
| X-ray Tube | Superior X-ray Tube Company SXR-130 1.2 mm, 65 kHU | D-125 CANON(TOSHIBA) & OX/125-1.2(CEI) 1.2mm, 35kHU | | |
| Collimator | Advantech | DGI | | |
| Flat-panel detector | None | Either RAYENCE 1717/SGC declared in K171419 or
1717/SCC declared in K171420
VIEWORKS VIVIX-S 1717V declared in K181003 | | |
| Flat-panel
detector
specifications | None | 1717/SGC: 127u 3,328 x 3,328 pixels
1717/SCC: 127u 3,328 x 3,328 pixels
VIVIX-S 1717V: 140u 3072 x 3072 pixels | | |
7
8
Image /page/8/Picture/2 description: The image contains two photos of a MINXRAY HF120/60HPPWV PowerPlus portable X-ray machine. The photo on the left shows the machine from a front three-quarters perspective, highlighting its yellow and black color scheme, control knobs, and collimator. The photo on the right shows the machine from a top-down perspective, with a blue circle drawn around it.
9
VII. Non-clinical testing:
| IEC 60601-1:2005/AMD1:
2012
EN 60601-1:2006/A1:2013 | Medical electrical equipment -- Part 1: General
requirements for basic safety and essential performance |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2:2014 /
EN60601-1-2:2015 | Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance
– Collateral standard: Electromagnetic disturbances –
Requirements and tests |
| EN 60601-1-3:2008/
A11:2016 | Medical electrical equipment - Part 1-3: General
requirements for basic safety and essential performance
- Collateral Standard: Radiation protection in diagnostic
X-ray equipment (IEC 60601-1-3:2008) |
| IEC 60601-2-54:2015/
EN 60601-2-54:2015 | Medical electrical equipment -- Part 2-54: Particular
requirements for the basic safety and essential
performance of X ray equipment for radiography and
radioscopy |
Testing was performed successfully according to the following standards:
Furthermore, the following Specific Guidance Document was utilized in the device development to ensure the safety of this device for both the operators and patients:
- . "The Content of Premarket Submissions for Software Contained in Medical Devices"
- . "Guidance for the Submission of 510(k) for Solid State X-ray Imaging devices"
- . Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017.
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 2005
- . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices issued on October 2018
All applicable aspects of these guidance documents listed in this 510(k) summary have been addressed. The device also conforms to the following:
- · 21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products
- · 21 CFR 1020.30: Diagnostic x-ray system and their major components
10
CONCLUSIONS VIII.
After analyzing bench tests, it is the conclusion of NEUF Inc. that the NFLK-2501 Portable X-ray Unit is as safe and effective as the predicate device, has the same indications for use, has few technological differences, which are addressed through performance testing and compliance with the standards listed above, thus rendering it substantially equivalent to the predicate device.